Independent Data Monitoring Committee Recommendation was Based on Review of Safety and Efficacy; Enrollment Expected to Complete in 2H 2026
Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that the independent Data Monitoring Committee (DMC) overseeing RESTORATiVE303, the pivotal Phase 3 trial of VE303 for prevention of recurrent Clostridioides difficile infection (CDI), has completed its first prespecified interim analysis and recommended that the study continue without modification.
The interim analysis was triggered when 50% of the planned enrollment of individuals with one or more recurrences of CDI at baseline had reached the Week 8 primary efficacy timepoint. Following an unblinded review of the accumulated safety and efficacy data, the DMC determined that efficacy to date has exceeded the prespecified futility threshold and that no significant adverse events or new safety signals had emerged. The DMC therefore recommended that the study continue as planned.
Upcoming RESTORATiVE303 Study Milestones
Vedanta anticipates completing enrollment of the RESTORATiVE303 study in the second half of 2026. A second interim analysis is also planned for earlier in the second half of 2026. The study is recruiting patients who have had one or more recurrences of CDI at baseline across more than 150 sites in approximately 20 countries.
